A Phase IV, Multi-center, Cross-sectional study to evaluate the I50L substitution among subjects experiencing virologic failure on a HAART regimen containing atazanavir (ATV)Protocol: version 2.0, 2004-07-14Amendment 1: version 1.0, 2005-01-04

Phase 1

• Conditions: Subjects experiencing virologic failure after a HAART regimen containing ATV

• Registration Number: EUCTR2004-002880-26-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-20
• Study Completion: 2009-03-31
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

- Subject must be able to understand the informed consent and to provide written
informed consent;
- Subjects currently on an antiretroviral regimen containing ATV with either: 1) a confirmed virologic rebound (an HIV RNA = 1000 copies/mL, after achieving a value
< 400 copies/mL on at least two consecutive measurements) or 2) an HIV RNA = 1000 copies/mL after 24 weeks of therapy. In both cases, HIV RNA = 1000 copies/mL must be confirmed by screening/enrollment measurement within 14-90 days of the first HIV RNA value. The subject must be on the ATV-containing HAART regimen at the time of enrollment. The confirming viral load at screening/enrollment must be plasma HIV-1 RNA level obtained by using the Roche Amplicor Ultrasensitive Assay (Version 1.5) (or other approved assay as agreed upon by the medical monitor).
- Men and women = 18 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- VL <1000 c/mL at the screening visit.
- Individuals exhibiting virologic failure on a HAART regimen that does not include
ATV.
- Subjects who are incapable to give informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified